NCT05509894

Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone

Post Marketing Surveillance (PMS) Study for Ngenla Prefilled Pen in Pediatric Patients Who Have Endogenous Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone in Korea

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 565 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.

Conditions

• Pediatric Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Ngenla	As provided in real world practice

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-09-23
• Completion: 2026-09-23
• First posted: 2022-08-22
• Last updated: 2026-01-27

Locations

1 site across 1 country: South Korea